Written 12/6/20
I have zero interest in writing about politics or controversial topics. Docsology exists to highlight timeless truths found in creation that reveal the character of God. But…let’s face it, medicine is in the news. And maybe it will help for me to speak out about the new COVID-19 vaccines being considered for FDA approval.
Stops and Starts and Stops
Suppose that you are a delivery driver, and your normal route takes you down a long stretch of rural highway. The road runs through various properties, and it is crisscrossed by numerous fences. In the course of normal deliveries you drive for a relatively short distance, but then you must get in and out of your vehicle to open and close gates. Often you have to wait for the owners of certain properties to unlock a gate or for a herd of cattle to clear the road. Suppose further that the safe speed limit on these country roads (they are gravel and dirt, after all) is just 30 miles per hour. Between the sluggish pace, the cows, and the frequent stops, a delivery run takes the better part of a day.
One day there is an urgently important delivery. Your boss stresses how vital this run will be and pledges all the resources of the company to make it happen rapidly. She also impresses upon you the importance of safety, for lots of eyes will be on your mission; and besides, if you (and your cargo) don’t arrive in one piece, then many people will suffer the consequences.
You rush out to your delivery van, only to find that it is already loaded with the precious cargo and filled with gas. That is courtesy of your coworkers, who have been pulled from their regular jobs to help you, so you don’t have to load the packages yourself or stop and buy gas, like usual. Helped by the head start, you approach the first fence and prepare to stop the van and race to the gate as quickly as possible. But it is wide open, and there is someone standing there, enthusiastically waving you through and even cheering.
It turns out that your mission is so crucial that the local sheriff and deputies have mobilized to help speed you on your way. They are stationed at the fences, so that you won’t have to slow down or stop. They have even shooed the cows from the roadway, tracked down the local landowners, and prepaid your tolls. Effortlessly you sail through wide open gateways that normally bog you down, waved through by friendly troopers. In comparison with the usual run, this one seems to fly by impossibly fast.
As you near your destination, you imagine the expressions of relief and gratitude on the faces of those who will receive this much-needed package ahead of schedule. But as you pull up triumphantly (or so you imagine), you are instead met with looks of concern when you step out of your vehicle.
As much as those who have been waiting want to be grateful, they are understandably worried that something is wrong. They figure there is no way that you could have arrived in such miraculous time, so they wonder whether you actually have the real package or a counterfeit. Others are concerned that you might have caused property damage along the way by crashing through gates, driving too fast, or shortcutting through pastures. Did you bring harm to their neighbors in your reckless haste?
But the reality is that you never deviated from the normal course of your delivery route or exceeded the maximum safe speed. There have been no shortcuts, no phony packages, no breakneck speed, no precarious driving. All the essential aspects of the delivery have been the same as always, but the overall process has been shortened. A large commitment of resources (time, money, and people) eliminated the usual delays and interruptions.
This is a picture of Operation Warp Speed, the plan for the unprecedented development of vaccines for COVID-19.
Step By Step
New medical interventions must be thoroughly tested before they are accepted for use. This vetting process is extremely involved and takes a great deal of time and money. And rightly so, when we consider the possible consequences, such as the horrific birth defects in 10,000 children whose mothers were given thalidomide in Europe in the 1950’s. (It is noteworthy that in the US, thalidomide was never approved for use by the FDA, underscoring the crucial role of a stringent regulatory process.)
Safety is the prime consideration of medical research. But safety is not enough. Treatments must be shown to be effective, as well. There is waste associated with ineffective therapies – financial waste, to be sure, but also the tragic waste of lost opportunity and false hope in those who undergo useless treatments.
Trials of new medical therapies usually go through three phases. After each stage is completed, there is an extensive analysis of the results. Then the researchers can decide foremost about safety and secondly whether the results are promising enough to justify the next phase of testing. Even to plan a stage prematurely runs a great financial risk. The treatment may fall short and be abandoned, effectively flushing all the hard work of brilliant minds and all the investment down the drain. Drug companies, research labs, and scientists carefully weigh these risks at each stage. Only if all looks well do they start planning the next phase.
Once all the phases are completed, the intervention is submitted to the FDA for intense scrutiny before consideration of approval. (This is where we currently stand with the Pfizer and the Moderna vaccines). Then, after approval, it is time to work (and spend more money) on the supply side. Where and how will the treatment be manufactured, marketed, shipped, and distributed?
Speed Without Haste
When we are told that the COVID-19 vaccines were developed with unprecedented rapidity, we are understandably skeptical, like those in my opening scenario. But just as my hypothetical delivery run managed to go off with unheard of speed and yet did not compromise safety, so the trials of the current vaccines do not appear to be rushed or cut short in terms of rigorous medical science. (This is currently being confirmed by independent observers.)
You see, there are ways to save time other than skimping on science. Opportunities abound to eliminate dead time by devoting resources of people and money. For example, to help those working on the current vaccines, other scientists were diverted from their own research. Application forms that might normally find themselves at the bottom of a stack were given the highest priority. Each phase was planned before the previous was completed. Once the data showed safety and effectiveness, the next phase could be initiated immediately, thus eliminating the usual gaps.
Finally the manufacturing and supply process began long before the trials were completed. In fact as I write this, we are possibly within a week of approval for Pfizer’s vaccine, and yet it has already been shipped. In other words the vaccine was actually made, packaged, and distributed even before FDA approval.
But what if the FDA does not approve the vaccines? What if the data show a lack of efficacy – or worse, a safety concern? It could happen. If so, all the money will be wasted. That is a risk that few companies would take. But the financial pledges made through Operation Warp Speed mean that the financial risk to the companies doing the research was reduced, freeing them to proceed from one phase to another without hesitation, just as you could cruise through the gates on your critical delivery run.
Other People’s Money?
Of course the enormous financial risk involved in rapid vaccine development was not really eliminated by Operation Warp Speed. It was balanced against other risks. The cost of delays, with the loss of life from the pandemic and the devastating economic implications of shut downs and quarantines, was simply worth the risk of losing money. And ultimately the financial risk was assumed by someone other than the companies.
Through Operation Warp Speed, the US government assumed the risk – or more properly, you and I, the taxpayers, did. In the end, it is all of us citizens holding open the gates and clearing the roads for those who are developing these vaccines. Even more importantly, we are also the ones who are awaiting the precious package that will hopefully soon be delivered.
Should we greet it with suspicion or enthusiasm? Do the studies guarantee that the vaccine will be effective and safe and that we should all rush out and get it? Both Pfizer’s and Moderna’s vaccines have been successfully tested in tens of thousands of people. Those are pretty robust numbers. But there is always the danger that once the vaccines are administered to much larger populations, there will be unanticipated problems. Every new treatment or intervention should be followed up with careful surveillance. That is the scientific way.
For this reason, I have always followed the dictum: “Do not be the first person to prescribe a new drug…or the last person.”
Almost always, that is.
I am a physician who comes in contact with COVID patients, and I also regularly treat those who are very high risk due to various comorbidities. I deal with the weakest among us. I plan to get the vaccine without hesitation or fear as soon as I am able. In my case I believe it is a way to love my neighbor as myself.
I am not in favor of a vaccine mandate. And I did not set out to write this to convince anybody to take the vaccine. I am simply trying to make clear how a vaccine could be developed in record time without compromising the science. I pray that I do not regret writing this someday. But especially if you are high risk, I would encourage you, as my neighbor, to get vaccinated for your own sake. Warp Speed may save your life.
Dr. Bill Maynard